Clinical Trials Directory

Trials / Completed

CompletedNCT00848016

Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery

A Phase II Study of the Orally Administered Negative Enantiomer of Gossypol (AT-101) in Patients With Advanced Adrenocortical Carcinoma (ACC)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
29 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial is studying how well gossypol acetic acid works in treating patients with recurrent, metastatic, or primary adrenocortical cancer that cannot be removed by surgery. Drugs used in chemotherapy such as gossypol acetic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description

PRIMARY OBJECTIVE: I. To determine the proportion of patients with recurrent, metastatic, or primary unresectable adrenocortical carcinoma who achieve an objective response to R-(-)-gossypol acetic acid. SECONDARY OBJECTIVES:: I. To evaluate the safety of this drug in these patients. II. To determine the progression-free and overall survival of these patients. OUTLINE: This is a multicenter study. Patients receive oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 2 years.

Conditions

Interventions

TypeNameDescription
DRUGR-(-)-gossypol acetic acidParticipants take 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Timeline

Start date
2009-02-01
Primary completion
2012-03-01
Completion
2012-06-01
First posted
2009-02-20
Last updated
2014-05-07
Results posted
2014-02-21

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00848016. Inclusion in this directory is not an endorsement.